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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Quality Engineer Lead - **Company:** Liberty Personnel Services, Inc. - **Location:** Radnor, PA, United States - **Experience:** Expert - **Salary:** $75,000 - $100,000 - **Contract:** Permanent contract - **Skills:** Microsoft Word, Microsoft Excel, Microsoft Outlook, Data Integrity, Document Management Systems, Failure Mode Effects Analysis, Microsoft Office, Statistical Process Control (SPC), Ishikawa - **Published:** November 10, 2026 - **Apply:** http://www.libertyjobs.com/findjobs-details.php?j_id=90560 ## About the Role * Bachelor's degree in engineering, Materials Science, or related technical field preferred; Associate's with strong experience considered * 3-5+ years of quality engineering or quality assurance experience in a manufacturing environment * Background in medical device, automotive, or similar regulated industry preferred * Proven analytical and problem-solving skills using root-cause analysis tools * Comfort working directly on the production floor with operators and technicians * Effective written and verbal communication skills and ability to work cross-functionally * Proficiency with Microsoft Office (Excel, Word, Outlook) * Experience with ERP systems and digital QMS platforms a plus * Experience with FMEA, MSA, SPC, or process validation preferred * Familiarity with medical device regulations or similar regulated environments a plus The Experience That Will Really Get Our Attention You're the quality engineer people call when there's a line-down issue or a nagging defect that just won't die. You're fluent in ISO 9001 and comfortable in ISO 13485, and you know how to translate findings on the floor into clean documentation, metrics, and durable CAPAs. Ideally, you've had internal auditor or Lead Auditor training, you work comfortably with Lean and Six Sigma tools, and you've seen how solid MSA, FMEA, and SPC can stabilize a process in a regulated environment. High-signal tools and experience: ISO 9001 * ISO 13485 * Internal auditor or Lead Auditor training * Six Sigma Green Belt * Six Sigma Black Belt * 8D * 5-Why * Fishbone diagrams * FMEA * MSA * SPC * CAPA * Nonconformance management * ERP systems * Digital QMS platforms, If you're looking to deepen your ISO 13485 and CAPA experience, sharpen your root-cause skills, and make visible impact on product and process quality, this is a strong next step., If you're ready to take ownership of quality on the floor and help push a regulated manufacturing operation to the next level, let's talk. ## Description You're not a clipboard quality engineer. You're the one who walks the line, digs into the data, and fixes the problem at the source. In this role, you'll be the driving force behind a ISO 9001 / ISO 13485 Quality Management System that has to perform every single day. You'll partner with production, engineering, and operations to make sure what ships out the door consistently meets demanding customer and regulatory expectations. You'll live at the intersection of process, product, and people - solving nonconformances, tightening controls, and pushing continuous improvement projects that actually move the needle. If you've done real root-cause work in a regulated manufacturing environment and love being out on the floor, we want to talk to you. What You'll Work On You'll own and improve the systems that keep quality real, not theoretical: * ISO 9001 and ISO 13485-compliant Quality Management System * Production and process quality on the manufacturing floor * Nonconforming material, CAPA, and continuous improvement initiatives * Risk management for regulated manufacturing * Quality metrics, reporting, and data-driven decision-making * Internal and external audit support * Supplier quality performance and SCAR support * Calibration and maintenance of measurement and test equipment You'll work with core quality and problem-solving tools like 8D, 5-Why, Fishbone, FMEA, MSA, SPC, and Lean / Six Sigma methods. Your challenge: keep quality tight while driving speed, throughput, and reliability on a live production floor. What You'll Be Doing * Supporting compliance to ISO 9001 and ISO 13485 standards across the facility * Reviewing and updating SOPs, work instructions, and quality records for document control * Supporting calibration and maintenance programs for measurement and test equipment * Contributing to risk management activities aligned with medical device manufacturing requirements * Partnering with manufacturing teams to resolve quality issues in real time on the production floor * Performing root-cause analysis on nonconformances, inspection escapes, and recurring defects using structured methods * Driving continuous improvement projects on inspection processes, cycle time, throughput, and data integrity * Developing and monitoring quality metrics such as PPM, yield, and scrap rates to spot trends and opportunities * Supporting customer complaint investigations and contributing to corrective actions * Supporting nonconforming material review and disposition activities * Leading or contributing to CAPA investigations, corrective/preventive action development, and effectiveness checks * Participating in process capability studies, MSA, SPC, and process validation as needed * Preparing for and supporting internal audits and external audits by registrars, customers, or corporate * Supporting supplier quality activities, including performance reviews, SCARs, and supplier audits or qualifications * Spending significant time on the production floor observing processes, collecting data, and resolving issues, quality engineer, quality engineering, quality assurance, QA engineer, ISO 9001, ISO 13485, medical device quality, automotive quality, regulated manufacturing, QMS, quality management system, CAPA, nonconforming material, NC process, root cause analysis, 8D, 5-Why, fishbone, Ishikawa, FMEA, MSA, SPC, Lean, Six Sigma, Green Belt, Black Belt, internal auditor, lead auditor, process validation, supplier quality, SCAR, production floor, manufacturing quality, quality metrics, PPM, yield, scrap rate, ERP, digital QMS, Radnor, King of Prussia